Identity
- Trade Name
- VACUETTE FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, clot activator FDA UDI
- Device Name
- VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, G-barcode label, non-ridged FDA UDI
- Model / Reference
- 486089 FDA UDI
- Description
- VACUETTE® TUBE 6 ml CAT Serum Clot Activator 13x100 red cap-black ring, G-barcode label, non-ridged FDA UDI
Identifiers
- Catalog Number
- 486089 FDA UDI
- Primary DI / UDI-DI
- 29120126130995 FDA UDI
- 510(k) Number
- K960858 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, clot activator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evacuated blood collection tube IVD, clot activator
Vacuette by Greiner Bio-One GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated blood collection tube IVD, clot activator.
- BD Vacutainer® Serum Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Serum — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Serum — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Serum Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Serum — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Serum — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Serum Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
Cleared under the same submission
K960858 also covers:
- VACUETTE — Greiner Bio-One GmbH
- VACUETTE — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
- Vacuette — Greiner Bio-One GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Greiner Bio-One GmbH
Sources (1)
- FDA UDI ac37a6ad-e73c-4870-98fe-d7c382672d58 36 fields · synced May 30, 2026